Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
15
Chronic liver disease
To evaluate whether the oral administration of zinc acexamate (ACZ) at a dose of 600mg/day (equivalent to 100mg/day of elemental zinc) to patients with cACLD, improves your prognosis by reducing expected clinical events and the risk of suffering from them during during study follow-up.
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 27 Jun 2022 → ongoing
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518242-24-00
- EudraCT number
- 2021-000680-74
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To evaluate whether the oral administration of zinc acexamate (ACZ) at a dose of 600mg/day (equivalent to 100mg/day of elemental zinc) to patients with cACLD, improves your prognosis by reducing expected
clinical events and the risk of suffering from them during during study follow-up.
Secondary objectives 9
- To assess whether the administration of ACZ improves the risk of first decompensation and what type.
- To assess whether it reduces the overall risk of clinically significant portal hypertension [CSPH] estimated by the model described.
- Assess whether it improves the risk of hepatocarcinoma.
- To study if it reduces the risk of bacterial infections.
- To assess whether it improves overall transplant-free survival.
- Assess whether it improves transplant-free survival in relation to liver related deaths.
- Assess whether liver function improves as measured by the Child-Pugh score and the MELD scale.
- To assess whether the effects on the main variable or on each of the secondary variables separately, correlate with blood zinc levels during treatment.
- To evaluate the possible adverse effects of treatment with ACZ.
Conditions and MedDRA coding
Chronic liver disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10001422 | Advanced chronic liver disease | 10019805 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients of both sexes with cACLD diagnosed by hepatic stiffness by transition elastography >15 kPa.
- Age between 18 and 80 years, both inclusive.
- Absence of previous or current decompensation.
- In women of childbearing age, a possible pregnancy will be ruled out by means of a pregnancy test prior to the start of the study. Once the test has been carried out, the woman must use an effective contraceptive method during sexual intercourse to be maintained from the days prior to the start of treatment, and will continue to use them while the treatment is ongoing, as well as until a few days after finishing it.
- Sign the informed consent.
Exclusion criteria 4
- History or current presence of hepatocarcinoma.
- Concomitant systemic disease, with low short-term prognosis for life.
- Pregnancy, breastfeeding, or refusal to use contraceptive measures whilst participating in the study.
- Patients with cACLD due to HBV on antiviral treatment and with cACLD due to HCV cured with antiviral treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of time-dependent clinical events during study follow-up, along with the distribution of CSPH risk estimated by the ANTICIPATE model. Clinical events are defined as the sum of: 1. Hepatic decompensation defined as the presence of clinical ascites, gastrointestinal bleeding due to portal hypertension, and hepatic encephalopathy. 2. Hepatocellular carcinoma. 3. Death from liver causes (considering non-hepatic death as a competitive risk). 4. Liver transplant.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2021116 · Product
- Active substance
- Zinc Acexamate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 66 Month(s)
- Authorisation status
- Authorised
- ATC code
- A02BX — OTHER DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- Marketing authorisation
- 56.926
- MA holder
- LABORATORIOS VIÑAS, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo has the same composition than imp except the active substance
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Joan Genescà
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Joan Genescà
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 300 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Central De Asturias
Digestive System Service, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario De Toledo
Digestive System Service, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital De La Santa Creu I Sant Pau
Gastroenterology and Hepatology Service, Carrer De San Quinti 89, 08041, Barcelona
Bellvitge University Hospital
Hepatology and Liver Transplant Unit Section. Digestive System, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Parc Tauli Hospital Universitari
Digestive System Service, Parc Del Tauli 1, 08208, Sabadell
Hospital General Universitario Gregorio Maranon
Digestive System Medicine Service, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Del Mar
Hepatology Section, Department of Gastroenterology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Germans Trias I Pujol
Digestive System Service, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Ramon Y Cajal
Gastroenterology and Hepatology Service, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Gastroenterology and Hepatology Unit, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitari De Girona Doctor Josep Trueta
Digestive System Service, Avinguda De Franca S/n, 17007, Girona
Hospital Clinic De Barcelona
Hepatology Service, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Miguel Servet
Digestive System Service, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Hepatology Service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Marques De Valdecilla
Gastroenterology and Hepatology Service, Avenida Valdecilla Sn, 39008, Santander
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2022-06-27 | 2022-07-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-518242-24-00_for publication | 5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_ICF General_ESP_for publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS General_ESP_for publication | 5.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Copinal_for publication | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Spain | Acceptable 2024-10-18
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-12 | Spain | Acceptable | 2025-02-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-14 | Spain | Acceptable | 2025-04-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-30 | Spain | Acceptable with conditions 2025-08-18
|
2025-08-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-26 | Spain | Acceptable with conditions 2026-02-27
|
2026-03-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-05-06 | Spain | Acceptable with conditions | 2026-05-08 |